Senior Scientist, Drug Product Manufacturing and Development

What You’ll Do:

This Senior Scientist will support ongoing activities for drug product formulation and manufacturing with external partners and CDMOs. This would include manufacturing process development and optimization, clinical supply manufacture, and commercial preparedness with a focus on oral solid dosage forms. The individual will have a working knowledge of drug product development through all stages of clinical development.

 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

 

Responsibilities:

• Support technology transfer, formulation, and process development, optimization, scale-up, and manufacturing of clinical supplies, acting as Kailera’s person-in-plant for activities critical to program success
• Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects
• Review master batch records and executed batch records to ensure product quality
• Author change controls, review specifications, change notifications, and manage manufacturing deviations as necessary, working closely with Kailera’s quality group
• Present formulation development and manufacturing updates to internal and external stakeholders periodically
• Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD, and NDA)

 

Required Qualifications:

• 5+ years of experience in solid-oral dosage form development. Technical expertise in unit operations common to solid oral dosage form (e.g., milling, wet/dry granulation, compression, and film-coating)
• Extensive experience with management of day-to-day activities at CDMO’s
• Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment
• Strong working knowledge of Microsoft suites and common scientific software
• Experience with design of experiment (JMP/Minitab)
• Experience using quality systems such as Veeva to author and approve documents
• Excellent verbal, written, and interpersonal skills
• Ability to travel up to 10-20% (domestic and international)

 

Preferred Qualifications:

• Experience in the GLP-1 space, late-stage development

 

Education:

• B.S. and 12+ years of experience, advanced degree with 10+ years, or a PhD with 5-8 years of experience
• Degree in Engineering, Pharmaceutical Sciences, Chemistry or closely related field